title: A phase 2 trial of azacitidine and gemtuzumab ozogamicin therapy in older patients with acute myeloid leukemia.
abstract: This trial tested the safety and efficacy of a regimen consisting of hydroxyurea followed by azacitidine, 75 mg/m(2) for 7 days, and gemtuzumab ozogamicin, 3 mg/m(2) on day 8, in older patients with newly diagnosed acute myeloid leukemia. Those achieving a complete remission received 1 consolidation treatment followed by 4 cycles of azacitidine. The patients were stratified into good-risk (age 60-69 years or performance status 0-1) and poor-risk (age ≥70 years and performance status 2 or 3) groups. Specific efficacy and safety goals were defined as being supportive of further study of the regimen. Eighty-three patients were registered in the good-risk cohort and 59 in poor-risk cohort, with median age of 71 and 75 years, respectively. In the good-risk group, 35 patients (44%) achieved a complete remission. Median relapse-free and overall survivals were 8 and 11 months, respectively. Six patients (8%) died within 30 days of registration. In the poor-risk group, 19 (35%) achieved a complete remission. Median relapse-free and overall survivals were 7 and 11 months, respectively. Seven patients (14%) died early. The results of this trial met predefined goals for efficacy and safety for the poor-risk cohort but not the good-risk group. .
authors.affiliation: Department of Medicine, Loyola University Medical Center, Maywood, IL;
authors.forename: Sucha
authors.initials: S
authors.lastname: Nand
authors.forename: Megan
authors.initials: M
authors.lastname: Othus
authors.forename: John E
authors.initials: JE
authors.lastname: Godwin
authors.forename: Cheryl L
authors.initials: CL
authors.lastname: Willman
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Norwood
authors.forename: Dianna S
authors.initials: DS
authors.lastname: Howard
authors.forename: Steven E
authors.initials: SE
authors.lastname: Coutre
authors.forename: Harry P
authors.initials: HP
authors.lastname: Erba
authors.forename: Frederick R
authors.initials: FR
authors.lastname: Appelbaum
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000617:Aminoglycosides / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001374:Azacitidine / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D000079982:Gemtuzumab; D006801:Humans; D006918:Hydroxyurea / Q000008:administration & dosage / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D017567:Karnofsky Performance Status; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D015479:Leukemia, Myelomonocytic, Acute / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D012306:Risk; D016019:Survival Analysis
chemical_list: D000617:Aminoglycosides; D061067:Antibodies, Monoclonal, Humanized; D000079982:Gemtuzumab; D001374:Azacitidine; D006918:Hydroxyurea